Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.

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Key information

Conditions

To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cosmedic Dermatology, Detroit, Michigan, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects of either gender, 18 years of age or older
Subject is able to read, understand and sign an informed consent form
Subject is willing to comply with all study procedures

Exclusion criteria

Subjects taking medicines that increase skin sensitivity to heat
Subjects taking medicines that change skin metabolism
Cancer or any pigmentary or vascular lesions in the planned treatment area
Subjects with Herpes simplex in the area to be treated
Pregnant women
Subjects wearing pacemakers and/or any other type of implanted electronics
Subjects with any inflammatory skin conditions
Subjects with active cold sores, open lacerations, abrasions
Chronic or acute skin infections
Subjects with active local or systemic infections
Subjects with any disease in which an increase of skin temperature is contraindicated
Subjects wearing piercing in the area to be treated
Subjects have nerve insensitivity to heat in the area to be treated
Subjects have metal implants in the area to be treated, excluding dental implants
Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
Any condition where the study investigator determined that the subject is not adequate for this study
Subjects participating in other studies

Treatment and study plan

NuEra Tight RF system

Device

monopolar radiofrequency device

Primary outcomes

tissue heating

Time frame: 12 minutes

To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating
temperature stability

Time frame: 12 minutes

To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability

Sponsors and collaborators

Lead sponsor

Lumenis Be Ltd.

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jul 24, 2023
Registry last updated: Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.